Know Cancer

forgot password

Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma



- Determine 2-year overall survival of patients with newly diagnosed, bulky stage II or
stage III or IV peripheral T-cell non-Hodgkin's lymphoma treated with cisplatin,
etoposide, gemcitabine, and methylprednisolone.


- Determine the toxicity of this regimen in these patients.

- Determine the response rate (complete unconfirmed response, complete response, and
partial response) in patients treated with this regimen.

- Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients receive cisplatin IV over 30-60 minutes, etoposide IV over 30-60 minutes, and
methylprednisolone IV over 5 minutes on days 1-4. Patients also receive gemcitabine IV over
30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-6 weeks, 3 months, and then
every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.

Inclusion Criteria


- Diagnosis of peripheral T-cell non-Hodgkin's lymphoma

- Newly diagnosed, relapsed or progressing disease after 1 prior treatment with a
non-platinum based chemotherapy (e.g., CHOP)

- Bulky stage II or stage III or IV disease

- The following histologies are not eligible:

- T-cell prolymphocytic leukemia

- T-cell large granular lymphocytic leukemia

- Any NK-cell leukemia

- Adult T-cell leukemia/lymphoma

- Mycosis fungoides/Sézary syndrome

- Lymphomatoid papulosis

- Nasal-type extranodal NK/T-cell lymphoma

- Enteropathy-type T-cell lymphoma

- Hepatosplenic T-cell lymphoma

- Subcutaneous panniculitis-like T-cell lymphoma

- Angioimmunoblastic T-cell lymphoma

- Primary cutaneous anaplastic large cell lymphoma (ALCL)

- ALCL with CD30, ALK, and EMA expression

- ALCL morphology that fails to express ALK or EMA allowed provided T-cell
lineage is confirmed by immunotyping or genetic testing

- Bidimensionally measurable disease

- Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the
original diagnostic specimen available

- Needle aspiration or cytology is not considered adequate samples

- No clinical evidence of Central nervous system (CNS) involvement by lymphoma



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 2 times upper limit of normal


- Creatinine clearance ≥ 30 mL/min


- No history of congestive heart failure

- No history of myocardial infarction

- No history of unstable angina

- No history of asymptomatic arrhythmias

- Ejection fraction normal by multigated acquisition (MUGA) scan (for patients with
questionable cardiac history)

- No other history of impaired cardiac status


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- Mild clinical hearing loss allowed provided patient is willing to accept the
potential for worsening of hearing loss

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- Must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and
pelvis within the past 28 days


Biologic therapy

- At least 3 weeks since prior biologic therapy

- No concurrent routine use of bone marrow colony-stimulating factors


- No other concurrent chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy for this cancer

- No concurrent radiotherapy


- Not specified


- No prior cytotoxic therapy for this cancer

- Concurrent enrollment in SWOG-8819 or SWOG-8947 allowed

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact

Outcome Time Frame:

0-2 years

Safety Issue:


Principal Investigator

Daruka Mahadevan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona


United States: Federal Government

Study ID:




Start Date:

September 2005

Completion Date:

March 2014

Related Keywords:

  • Lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • anaplastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
CCOP - Montana Cancer Consortium Billings, Montana  59101
Kaiser Permanente Medical Center - Vallejo Vallejo, California  94589
Kaiser Permanente Medical Center - San Francisco Geary Campus San Francisco, California  94115
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Santa Clara, California  95051-5386
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Kaiser Permanente - Fremont Fremont, California  94538
Kaiser Permanente Medical Center - Hayward Hayward, California  94545
South Sacramento Kaiser-Permanente Medical Center Sacramento, California  95823
Kaiser Permanente Medical Center - Santa Teresa San Jose, California  95119
Kaiser Foundation Hospital - San Rafael San Rafael, California  94903
Kaiser Permanente Medical Center - Santa Rosa Santa Rosa, California  95403
Kaiser Permanente Medical Center - South San Francisco South San Francisco, California  94080
Kaiser Permanente Medical Facility - Stockton Stockton, California  95210
Kaiser Permanente Medical Center - Walnut Creek Walnut Creek, California  94596
Louisiana State University Health Sciences Center - Monroe Monroe, Louisiana  71210
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Highland Clinic Shreveport, Louisiana  71105